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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL-FTM

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL-FTM Back to Search Results
Model Number CMCV-009-MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 05/11/2021
Event Type  Injury  
Manufacturer Narrative
No sample was returned for investigation. Manufacturing review of the referenced lot number and respective device history record was conducted on 18may2021, showing that all units were quality released on 28dec2020 having met all internal qc acceptance requirements. There were no non-conformances associated with the manufacturing lot during the final packaging. Sterile subassembly lot m20f1184 was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 07july2020 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements. In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing. A review of the instructions for use (ifu-art-20662c) provided with the finished cangaroo envelope device states under the section potential complications: the following device-related complications are possible: hematoma and infection. The patient's history mentions several vascular access ports as well as the possibility that she is a cancer patient. Reported adverse events potentially related to treatments for associated comorbidities. No further information is available reqarding this event, should any additional information be received, a follow-up report will be filed.
 
Event Description
It was reported on (b)(6) 2021 by aziyo business partner biotronik that a cangaroo envelope (model cmcv-009-med, lot# m20n1418) was used in an initial pacemaker implant procedure on (b)(6) 2021 on a female patient. Envelope was prepared by soaking in saline for 1 - 2 minutes. Patient was seen in emergency department on (b)(6) 2021 with swelling and bruising around her pacemaker and potential envelope infection. The patient was placed on iv antibiotics. Device was explanted (b)(6) 2021 and patient is being re-evaluated if another device will be implanted at a later date. No further information was provided despite requests for additional details. Should any additional information be received, a follow-up report will be filed.
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, SURGICAL-FTM
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer (Section G)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer Contact
michael hennick
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key11958003
MDR Text Key266395353
Report Number3005619880-2021-00019
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-MED
Device Lot NumberM20N1418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2021 Patient Sequence Number: 1
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